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ORIGINAL ARTICLE
Year : 2014  |  Volume : 10  |  Issue : 5  |  Page : 38-41

Kanglaite injection combined with hepatic arterial intervention for unresectable hepatocellular carcinoma: A meta-analysis


1 Department of Radiology, Tianjin Hospital, Tianjin, China
2 Department of Gastrointestinal Thyroid Surgery, the First Affiliated Hospital of Shihezi University, Shihezi, Xinjiang Uygur Autonomous Region, China
3 Department of Interventional Radiology, The First Hospital Affiliated to Henan University, Henan, China

Date of Web Publication30-Aug-2014

Correspondence Address:
Yeda Wan
Department of Radiology, Tianjin Hospital, Tianjin, 300050
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0973-1482.139753

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 > Abstract 

Objective: The purpose of this study was to evaluate the Kanglaite (KLT) injection combined with hepatic arterial intervention for treatment of unresectable hepatocellular carcinoma (HCC) by meta-analysis.
Materials and Methods: Computerized bibliographic searching were undertaken to identify all eligible published studies about the KLT injection combined with hepatic arterial intervention for unresectable hepatocellular carcinoma (HCC). PubMed, EMBASE, Chinese National Knowledge Infrastructure (CNKI) and Wanfang databases were all searched to included the suitable trails. The odds ratios (ORs) and its corresponding 95% confidence intervals (95% CIs) were calculated as effect size with fixed-effect or random-effect models according to the heterogeneity test across the studies.
Results: Nine trails were finally included in this meta-analysis. The objective response rate (ORR) was significant improved in the group of KLT injection combined with hepatic arterial intervention compared to hepatic arterial intervention alone (OR =1.80, 95% CI:1.18-2.75, P < 0.05); The combined treatment can significant improve the KSP score (OR = 3.22, 95% CI:1.36-7.60, P < 0.05) and relief the pain of patients compared to that in single treatment (OR = 2.57, 95% CI:1.65-3.99, P < 0.05).
Conclusion: KLT injection combined with hepatic arterial intervention can improve the short-term clinical efficacy, quality of life, and decrease the pain of patients with unresectable HCC.

Keywords: Hepatocellular carcinoma, kanglaite injection, meta-analysis


How to cite this article:
Fu F, Wan Y, Mulati, Wu T. Kanglaite injection combined with hepatic arterial intervention for unresectable hepatocellular carcinoma: A meta-analysis. J Can Res Ther 2014;10, Suppl S1:38-41

How to cite this URL:
Fu F, Wan Y, Mulati, Wu T. Kanglaite injection combined with hepatic arterial intervention for unresectable hepatocellular carcinoma: A meta-analysis. J Can Res Ther [serial online] 2014 [cited 2021 Feb 24];10:38-41. Available from: https://www.cancerjournal.net/text.asp?2014/10/5/38/139753

Yeda Wan and Tao Wu contribute equally to this work



 > Introduction Top


Hepatocellular carcinoma in men is the fifth most frequently diagnosed cancer worldwide but the second most frequent cause of cancer death. An estimated 748,300 new liver cancer cases and 695,900 cancer deaths occurred worldwide in 2008. [1] Half of these cases and deaths were estimated to occur in China. [2] Thus China had the highest burden of hepatocellular carcinoma (HCC) of the world. In developing countries, more 50% HCC patients are diagnosed at the late stage, in which the patients cannot be manipulated by surgery. For patients with advanced clinical stage or metastasis lesion, they are always treated by conservative therapy such as systematic chemotherapy, hepatic arterial intervention etc.

According to the National Comprehensive Cancer Network (NCCN) guideline, the systematic chemotherapy or hepatic arterial intervention can prolong the patient's life expectancy. But the cell toxicity chemotherapy drug can also impair the patient's immune system and decrease the patient's life quality. Thus, how to elevate the chemotherapy efficacy and reduce the side effects of toxicity drug is main problem when treating the HCC. Recently, several studies demonstrated that one of Chinese herb preparations Kanglaite (KLT) can improve the patient's life quality when administered the chemotherapy or hepatic arterial intervention in patients with HCC. But the small patients number included in each trails made these articles' results limitation. So, we performed this meta-analysis to further evaluation the clinical efficacy of KLT injection combined with hepatic arterial intervention for unresectable HCC.


 > Materials and methods Top


Literature source and search strategy

We performed the electronic search on the data bases of PubMed, EMBASE, Chinese National Knowledge Infrastructure and Wanfang. The following key words or text words were used when search for the relevant articles. "hepatocellular carcinoma","liver carcinoma", "hepatocellular cancer" AND "Kanglaite,". The search was done on studies conducted on human subjects, without restriction on language.

Inclusion criteria

The inclusion criteria were: (1) patients included in each trails were cytologically or pathologically confirmed cases of hepatocellular cancer; (2) patients were given KLT injection combined with hepatic arterial intervention or hepatic arterial intervention alone;(3) short-term efficacy such as complete response, partial response or objective response rate should be provided in results of each study;(4) the study design should be prospective randomized controlled trails (RCTs).

Data extraction

Two reviewers independently evaluated and retrieved the relevant studies, and the disagreements were resolved by discussion or consulting to another reviewer according to the Cochrane handbook. The general characteristics such as the first author, year of publication, treatment of regimen for each arm, patients included in each arm were extracted. The frequency for interested events such as complete response, partial response, patient number with KPS improvement and pain relief in the combined treatment and control groups were extracted carefully by on reviewed and confirmed by another reviewer.

Quality assessments

The quality of the included studies was assessed by a six-questionnaire according to the Cochrane protocol for evaluation of clinical randomized trials. The question questions are: (a) Adequate sequence generation?; (b) Allocation concealment?; (c) Incomplete outcome data addressed?; (d) Free of selective reporting?; and (f) Free of other bias? The quality evaluation procedure was performed by two reviewers and discussed in case of disagreements.

Statistical analysis

All of the data were analyzed using Revman 5.0 (Cochrane Collaboration, Denmark). The Chi-square test was used to evaluate the heterogeneity across the studies for its separate effect size with statistical significance of P = 0.1. If P < 0.1, the randomized effect model was used to pool the results, otherwise the fixed effect model was purchased. The odds ratios (OR) among the frequency of events in both combined treatment and single were calculated and were presented as a point estimate with 95% confidence intervals (CI) and P values in parentheses.


 > Results Top


General characteristic and quality evaluation

According to the inclusion and exclusion criteria, nine trails [3],[4],[5],[6],[7],[8],[9],[10],[11] including 608 cases with HCC were finally included in this meta-analysis. Eight studies administered KLT with 200 ml intravenously guttae (ivggt) quaque die/every day (qd) and 1 study with [Table 1] KLT 100 ml; The KLT administered period range 10-42 days. For quality assessment, one study detailed the adequate sequence generation, one trail explained the incomplete data address and three studies reported the free of selected reporting. The general quality of the included nine trails is low [Figure 1].
Figure 1: The quality evaluation of included trails

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Table 1: General characteristics of the included nine trials


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Objective response

The pooled results showed that objective response rate (ORR) was significantly improved in the group of KLT injection combined with hepatic arterial intervention compared to hepatic arterial intervention alone (OR =1.80, 95% CI: 1.18-2.75, P < 0.05) [Figure 2]. The heterogeneity test indicated that there was no statistical significance heterogeneity across the included studies (P = 0.98).
Figure 2: The forest plot of odds ratio for evaluation of objective response rate

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Karnofsky score improvement

Three trails reported the events with Karnofsky score improvement. The pooled data indicated that combined treatment can significant improve the KSP score (OR = 3.22, 95% CI: 1.36-7.60, P < 0.05) [Figure 3].
Figure 3: The forest plot of odds ratio for evaluation of Karnofsky score improvement

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Pain relief

Five trails provided the data of pain relief, and the pooled results demonstrated KLT injection combined with hepatic arterial intervention can significant relief the pain of patients with HCC compared to treatment of hepatic arterial intervention alone (OR = 2.57, 95% CI: 1.65-3.99, P < 0.05) [Figure 4].
Figure 4: The forest plot of odds ratio for evaluation of pain relief

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Publication bias

No significant publication bias was found according to the funnel plots of each effect size [Figure 5].
Figure 5: Funnel plot for each effect size (a: Objective response rate; b: KPS score; c: Pain relief)

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 > Discussion Top


Primary liver cancer is the second most common malignancy, and currently results in 360,000 incident cases, and 350,000 deaths a year in China. [12],[13] For the past four decades, three national surveys on cancer mortality during the periods of 1973-1975, 990-1992 and 2004-2005 have made it possible to estimate China's past and present liver cancer epidemic. [14] The mortality rates of liver cancer were 17.6 and 7.3 per 100,000 for males and females in 1973-1975, 29.0 and 11.2 per 100,000 in 990-1992, and 37.55 and 14.45 per 100,000 in 2004-2005, respectively. [12] So, liver cancer was serious public problem in China. Among primary liver cancers, HCC represents the major histological subtype, accounting for 70%-85% of the total liver cancer burden worldwide. In developing countries, more 50% HCC patients are diagnosed at the late stage, in which the patients cannot be manipulated by surgery. For patients with advanced clinical stage or metastasis lesion, they are always treated by conservative therapy such as systematic chemotherapy, hepatic arterial intervention etc. But patients received hepatic arterial intervention or chemotherapy always suffered from side effects related to the treatment itself. So the question of how to reduce side effects arise from hepatic arterial intervention treatment which was a big problem related to treatment efficacy. Several studies demonstrated KLT injection can improve the clinical efficacy and quality of life in HCC patients who received the hepatic arterial intervention or chemotherapy.

KLT injection is one of Chinese herb preparations that is developed and manufactured by Zhejiang Kanglaite Pharmaceutical Co., Ltd in China. [15] It has demonstrated that KLT can be used for several types of carcinomas. Published clinical study indicated that KLT injection can inhibit cancer cells directly and effectively at the same time improving patient immune function; KLT injection can also increase the chemotherapy efficacy and reduce toxicity in patients with chemotherapy. In this meta-analysis, we included nine clinical trials about the KLT injection combined with hepatic arterial intervention treatment. The pooled results showed the ORR was significantly improved in the group of KLT injection combined with hepatic arterial intervention compared to hepatic arterial intervention alone group (OR =1.80, 95% CI: 1.18-2.75, P < 0.05); The results indicated that KLT injection can improve the short-term clinical efficacy. But without enough long-term flow-up data, the pooled overall survival was not calculated. This is a main drawback of this meta-analysis. The pooled data also indicated the combined treatment can significantly improve the KSP score (OR =3.22, 95% CI: 1.36-7.60, P < 0.05) and relief the pain of patients compared to that in single treatment (OR =2.57, 95% CI: 1.65-3.99, P < 0.05). The pooled results demonstrated KLT injection can also improve the quality of life in patient who received the hepatic arterial intervention treatment.

 
 > References Top

1.Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.  Back to cited text no. 1
    
2.Ferlay J, Shin HR, Bray F, Forman D, Mathers CD, Parkin D. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10. Lyon, France: International Agency for Research on Cancer; Year. Available from: http://globocan.iarc.fr. 2010 [Last accessed on 2010 Aug 17].  Back to cited text no. 2
    
3.Wang HL, Chen Y. The clincial efficacy of Kanglaite injection in the treatment of primary liver cancer. J Qilu Tumour 1999;6:159.  Back to cited text no. 3
    
4.Ye XZ, Song BY, Liu JH. Kanglaite injection combined with hepatic arterial intervention in the treatment of advanced hepatocellular carcinoma. Chin J Clin Med 2003;4:23-5.  Back to cited text no. 4
    
5.Hu JB, Liu SL, Zhou HL. Kanglaite injection combined with hepatic arterial intervention chemotherapy in the treatment of advanced lover cancer. Shanxi Oncol Med 2003;11:48-9.  Back to cited text no. 5
    
6.Lv DZ. Kanglaite injection combined with hepatic arterial intervention assistant treatment of liver cancer. N Chin Med 2004;35:415-6.  Back to cited text no. 6
    
7.Zhu XF. The clinical observation of the effect of Kanglaite injection combined with chemoembolization primary on middle and advanced stage liver cancer. J Basic Clin Oncol 2006;19:132-4.  Back to cited text no. 7
    
8.Lu HZ, Xu XD. Effects of transcatheter arterial chemoenbolization combined with Kanglaite injection on patients with advanced unrespectable hepatocellular carcinoma. Cent Plains Med J 2006;133:3-4.  Back to cited text no. 8
    
9.Liang SM, Song J. Kanglaite combined with transcatheter arterial chemoenbolization in the advanced premier liver cancer. Chinese Journal of Modern Applied Pharmacy 2006;23:825-6.  Back to cited text no. 9
    
10.Jiang YB. The efficacy of Kanglaite injection in the treatment of primary liver cancer. J Mod Oncol 2006;14:485-6.  Back to cited text no. 10
    
11.Yin RR. Hepatic arterial intervention combined with Kanglaite injection in the treatment of primary liver cancer. China Foreign Med Treat 2009;28:78.  Back to cited text no. 11
    
12.Chen JG, Zhang SW. Liver cancer epidemic in China: Past, present and future. Semin Cancer Biol 2011;21:59-69.  Back to cited text no. 12
    
13.Chen JG, Chen WQ, Zhang SW, Zheng RS, Zhu J, Zhang YH. Incidence and mortality of liver cancer in China: An analysis on data from the National Registration System between 2003 and 2007. Zhonghua Liu Xing Bing Xue Za Zhi 2012;33:547-53.  Back to cited text no. 13
    
14.The Editorial Committee. Atlas of cancer mortality in the People's Republic of China. Shanghai: China Map Press; 1979. p. 1-99.  Back to cited text no. 14
    
15.Zhan YP, Huang XE, Cao J, Lu YY, Wu XY, Liu J, et al. Clinical safety and efficacy of Kanglaite® (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev 2012;13:5319-21.  Back to cited text no. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1]



 

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